Avinger (NASDAQ:AVGR) has filed for 510(k) clearance of its Pantheris small-vessel “lumivascular” atherectomy device for treatment of peripheral artery disease (PAD). The Pantheris small vessel (SV) device extends the company’s line of Pantheris catheters, the first and only image-guided atherectomy devices for the treatment of PAD, which is estimated to affect over 12 million people in the […]
Avinger
Avinger posts loss on disappointing sales
Avinger (NSDQ:AVGR) today posted a second-quarter losses-per-share that missed an analyst’s expectation, sending its share price down on Wall Street despite nearly halving its losses. The Redwood City, Calif.-based medical device maker reported losses of -$6.6 million, or -98¢ per share, on sales of $2.1 million for the three months ended June 30, 2018. That compares with […]
Avinger receives FDA approval for Pantheris altherectomy device
Avinger (Redwood City, Calif.) recently received FDA approval for its Pantheris image-guided altherectomy device that is designed to treat peripheral artery disease (PAD). Pantheris is the first medical device to be approved for diagnostics and treatment of PAD. The device lets doctors see inside arteries to treat blockages. It features a built-in camera and can […]
Avinger prices $4m offering
Avinger (NSDQ:AVGR) today priced an upcoming offering worth $3.6 million. The Redwood City, Calif.-based company said it is looking to float approximately 2.2 million shares of its common stock at $1.64 per share, hoping to bring in approximately $3.6 million. The offering will also include warrants for the purchase of half a share of common stock […]
Avinger launches next-gen Pantheris in US
Avinger (NSDQ:AVGR) said today it launched its next-generation Pantheris in the US, touting that the first procedures with the device have already been performed. Redwood City, Calif.-based Avinger said the newly launched Pantheris device features a single-balloon system designed both for apposition and blood flow occlusion and improved pushability and tissue storage capacity. The system is designed […]
Avinger launches post-market study comparing OCT to IVUS in PAD treatments
Avinger (NSDQ:AVGR) said today it launched a post-market study comparing optical coherence tomography to intravascular ultrasound as used during interventions in the peripheral arteries. The Redwood City, Calif.-based company’s Lumivascular tech, including its Pantheris image-guided atherectomy device and Ocelot image-guided chronic total occlusion crossing catheters, use OCT for real-time intravascular imaging during interventions to treat peripheral […]
Avinger wins FDA nod for next-gen Pantheris
Avinger (NSDQ:AVGR) said today it won FDA 510(k) clearance for its next-gen Pantheris lumivascular atherectomy system, which it touts as the first image-guided atherectomy device designed for treating peripheral artery disease. Redwood City, Calif.-based Avinger said the newly cleared Pantheris device features a simpler, single-balloon system designed both for apposition and blood flow occlusion and improved pushability […]
Update: Avinger shares rise on Q1 earnings
Updated to reflect corrected financial data from Avinger. Shares in Avinger (NSDQ:AVGR) rose today after the medical device maker posted first quarter earnings that saw losses shrinking, despite missing consensus on Wall Street. The Redwood City, Calif.-based company posted losses of $15.9 million, or $7.99 per share, on sales of $1.8 million for the three months […]
Avinger touts 1st use of extended-nosecone Pantheris cath
Avinger (NSDQ:AVGR) said today it launched its Pantheris lumivascular atherectomy system with extended nosecone in the European Union, touting that the device has been used in its first human patients. The device was used by Dr. Arne Schwindt in treating peripheral artery disease in three patients at Münster, Germany’s St. Franziskus Hospital, the Redwood City, Calif.-based company […]
Avinger settles class-action investors suit for $5m
Avinger (NSDQ:AVGR) said today it inked a $5 million deal to settle a class-action investors suit against the company and several of its officers and directors. The deal comes after the company took part in a mediation related to the suit on February 8, which it said began discussions that ultimately led to the settlement. The Redwood […]
Avinger shares dive on Q4 sales slide
Shares in Avinger (NSDQ:AVGR) have tumbled today after the medical device maker missed expectation on Wall Street with its fourth quarter and full year 2017 earnings. The Redwood City, Calif.-based company posted losses of $8.6 million, or $12.58 per share, on sales of $1.9 million for the 3 months ended December 31, seeing losses shrink 28.2% […]
